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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02538445
Other study ID # 1001156
Secondary ID 2010-A01372-37
Status Completed
Phase N/A
First received August 31, 2015
Last updated March 22, 2016
Start date May 2011
Est. completion date December 2012

Study information

Verified date August 2015
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
Study type Interventional

Clinical Trial Summary

Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.


Description:

Researchers used the directed forgetting paradigm composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria for patients:

- Schizophrenic patients as defined in Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)

- Stabilized a therapeutic point of view for at least one month.

- Consent form signed

- Affiliated to a Security Health Program

Inclusion Criteria for volunteers:

- Consent form signed

- Affiliated to a Security Health Program

Exclusion Criteria for patients and volunteers :

- Not having a history of head trauma, neurological disease or not stabilized serious somatic illness,

- Not to use psychoactive substance, as defined by the DSM IV.

- The Intelligence Quotient must not be less than 70 (Progressive Matrices Standard score (PM38), Raven Progressive Matrix).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Memorization of the verbs by miming the action
The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.
Memorization of the verbs by imagining the action
The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.
Memorization of the action verbs by means of another word
The participant reads aloud the verbs that appear on the screen. Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one. The word is written near the action verb.
Simple memorization of the verbs
The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).

Locations

Country Name City State
France CHU de SAINT-ETIENNE Saint Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of items recalled TBR and TBF It is asked to the participants to recall orally, only TBR verbs (task of reminder). The experimenter notes the given verbs. Day 1 No
Secondary Number of recognized items Participants must recognize TBR verbs among several verbs (distractor or TBF verbs) on the screen.The experimenter notes the recognized verbs.
The recognition of a verb in the TBF list or a distractor is considered like an error.
Day 1 No
Secondary Reaction time (ms) on the recognition of TBR and TBF The response times of participants are recorded in ms. Day 1 No
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